Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia; Sleep; Insomnia Chronic
• Intervention / Treatment: Device: Fisher Wallace Neurostimulation Device

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • ProofPilot (Remote Virtual Trial)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Read/write English Insomnia Severity Index Score Greater than 14 Diagnosis of insomnia by a medical physician Subjects with a Generalized Anxiety Diagnosis will be excluded Have not contemplated suicide in the past year Not been institutionalized for mental health issues. Not currently being treated for or suspect a mental health issue Not currently experiencing problems with alcohol or drug abuse Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study Not taking medications affecting the nervous system (e.g. psychiatric medications) Not taking hypnotics or any sleep aid or marijuana (in any form) Can commit to one (1) 20 minute session per day for 8 weeks Has not used a brain stimulation treatment in one year No suspected or known history of heart disease No pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc.

Not under medical supervision for other serious medical condition Not taking opioids No pain or headaches that interrupt sleep Not participating in any other sleep study Not experiencing restless leg syndrome No Nickel Allergy No Sleep Apena as measured by STOP-Bang Assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experiment Arm; Active Fisher Wallace device for full 8 weeks	Device: Fisher Wallace Neurostimulation Device; a Cranial Electrotherapy Stimulator Device (CES).
SHAM_COMPARATOR: Sham Arm; Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.	Device: Fisher Wallace Neurostimulation Device; a Cranial Electrotherapy Stimulator Device (CES).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total sleep per night at week 4 between active and sham arm	Measured by Fitbit Charge 4 connected health device work on the wrist	baseline versus week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Tolerance and Safety measured by SAFTEE	assessment of safety and adverse events	4 weeks from baseline
Change in WASO (wake after sleep onset) between sham versus active arms	measured by Fitbit Charge 4 connected health device worn on the wrist	baseline versus week 4
Change in Insomnia Severity between Sham versus active arms	measured by the self report Insomnia Severity Index (ISI)	baseline versus week 4

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Fisher Wallace

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): January 31, 2021
• Study Completion (ANTICIPATED): February 21, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No